U.S. patent application number 13/857812 was filed with the patent office on 2013-08-29 for effervescent nutritional and/or dietary supplement composition.
This patent application is currently assigned to Nordic Naturals, Inc.. The applicant listed for this patent is Nordic Naturals, Inc.. Invention is credited to Joar Opheim.
Application Number | 20130224304 13/857812 |
Document ID | / |
Family ID | 42631179 |
Filed Date | 2013-08-29 |
United States Patent
Application |
20130224304 |
Kind Code |
A1 |
Opheim; Joar |
August 29, 2013 |
EFFERVESCENT NUTRITIONAL AND/OR DIETARY SUPPLEMENT COMPOSITION
Abstract
An effervescent composition is provided comprising a dry,
free-flowing powder comprising (a) microcapsules comprising a
hollow, solid, water soluble outer shell comprising a starch, a
sugar or mixtures thereof and an inner core comprising a liquid,
water immiscible oil comprising at least one polyunsaturated fatty
acid, at least one derivative of a polyunsaturated fatty acid or
mixtures thereof, and (b) an effervescing agent.
Inventors: |
Opheim; Joar; (Aptos,
CA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Nordic Naturals, Inc.; |
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US |
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Assignee: |
Nordic Naturals, Inc.
Watsonville
CA
|
Family ID: |
42631179 |
Appl. No.: |
13/857812 |
Filed: |
April 5, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12392833 |
Feb 25, 2009 |
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13857812 |
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Current U.S.
Class: |
424/493 ; 424/44;
426/2; 426/591 |
Current CPC
Class: |
A23L 33/30 20160801;
A61K 9/0007 20130101; A61K 9/5036 20130101; A23L 33/12 20160801;
A23L 2/40 20130101 |
Class at
Publication: |
424/493 ; 424/44;
426/591; 426/2 |
International
Class: |
A23L 1/29 20060101
A23L001/29; A61K 9/50 20060101 A61K009/50; A61K 9/46 20060101
A61K009/46 |
Claims
1. An effervescent composition comprising a dry, free-flowing
powder comprising (a) microcapsules comprising a hollow, solid,
water soluble outer shell comprising a starch, a sugar or mixtures
thereof and an inner core comprising a liquid, water immiscible oil
comprising at least one polyunsaturated fatty acid, at least one
derivative of a polyunsaturated fatty acid or mixtures thereof, and
(b) an effervescing agent.
2. The effervescent composition of claim 1 wherein the composition
is selected from the group consisting of a dietary supplement,
nutritional supplement, nutraceutical, medicinal formulation or
combinations thereof.
3. The effervescent composition of claim 1 wherein the starch
comprises sodium octenyl succinate.
4. The effervescent composition of claim 1 wherein the sugar
comprises glucose syrup.
5. The effervescent composition of claim 1 wherein the liquid,
water immiscible oil comprises a marine oil.
6. The effervescent composition of claim 5 wherein the marine oil
comprises fish oil.
7. The effervescent composition of claim 1 wherein the liquid,
water immiscible oil comprises at least one omega-3 polyunsaturated
fatty acid, at least one derivative of an omega-3 polyunsaturated
fatty acid, or mixtures thereof.
8. The effervescent composition of claim 7 wherein the liquid,
water immiscible oil comprises ethyl esters of omega-3
polyunsaturated fatty acids.
9. The effervescent composition of claim 7 wherein the liquid,
water immiscible oil comprises glycerides of omega-3
polyunsaturated fatty acids.
10. The effervescent composition of claim 1 wherein the
polyunsaturated fatty acid or derivative of a polyunsaturated fatty
acid comprises DHA, EPA, derivatives of DHA, derivatives of EPA or
mixtures thereof.
11. The effervescent composition of claim 10 wherein the derivative
of a polyunsaturated fatty acid is in the form of ethyl esters DHA,
ethyl esters of EPA, or mixtures thereof.
12. The effervescent composition of claim 10 wherein the derivative
of a polyunsaturated fatty acid is in the form of glycerides of
DHA, glycerides of EPA, or mixtures thereof.
13. The effervescent composition of claim 1 wherein the
effervescing agent comprises an acidic agent and an alkaline
agent.
14. The effervescent composition of claim 1 wherein the
effervescent composition comprises about 40% by weight of a liquid,
water immiscible oil comprising at least one polyunsaturated fatty
acid, at least one derivative of a polyunsaturated fatty acid or
mixtures thereof, about 48% by weight of a combination of sugar and
starch and about 12% by weight other ingredients.
15. The effervescent composition of claim 14 wherein the
effervescent composition comprises about 10% by weight EPA, DHA or
derivatives thereof.
16. The effervescent composition of claim 1 further comprising a
sweetening agent, flavor agent, color agent or mixture thereof.
17. The effervescent composition of claim 16 wherein the sweetening
agent is stevia.
18. A method of administering a liquid, water immiscible oil
comprising at least one polyunsaturated fatty acid, at least one
derivative of a polyunsaturated fatty acid or mixtures thereof to a
subject comprising (1) providing an effervescent composition
comprising a dry, free-flowing powder comprising (a) microcapsules
comprising a hollow, solid, water soluble outer shell comprising a
starch, a sugar or mixtures thereof and an inner core comprising a
liquid, water immiscible oil comprising at least one
polyunsaturated fatty acid, at least one derivative of a
polyunsaturated fatty acid or mixtures thereof, and (b) an
effervescing agent, (2) mixing the effervescent composition with an
aqueous liquid, and (3) administering the resulting mixture to the
subject.
19. The method of claim 18 wherein the effervescent composition is
selected from the group consisting of a dietary supplement,
nutritional supplement, nutraceutical, medicinal formulation or
combinations thereof.
20. The method of claim 18 wherein the starch comprises sodium
octenyl succinate.
21. The method of claim 18 wherein the sugar comprises glucose
syrup.
22. The method of claim 18 wherein the liquid, water immiscible oil
comprises a marine oil.
23. The method of claim 22 wherein the marine oil comprises fish
oil.
24. The method of claim 18 wherein the liquid, water immiscible oil
comprises at least one omega-3 polyunsaturated fatty acid, at least
one derivative of an omega-3 polyunsaturated acid, or mixtures
thereof.
25. The method of claim 24 wherein the liquid, water immiscible oil
comprises ethyl esters of omega-3 polyunsaturated fatty acids.
26. The method of claim 24 wherein the liquid, water immiscible oil
comprises glycerides of omega-3 polyunsaturated fatty acids.
27. The method of claim 18 wherein the polyunsaturated fatty acid
or derivative of a polyunsaturated fatty acid comprises DHA, EPA,
derivatives of DHA, derivatives of EPA, or mixtures thereof.
28. The method of claim 27 wherein the derivatives of DHA and
derivatives of EPA comprise ethyl esters of DHA, ethyl esters of
EPA, or mixtures thereof.
29. The method of claim 27 wherein the derivatives of DHA and
derivatives of EPA comprise glycerides of DHA, glycerides of EPA,
or mixtures thereof.
30. The method of claim 18 wherein the effervescing agent comprises
an acidic agent and an alkaline agent.
31. The method of claim 18 wherein the effervescent composition
comprises about 40% by weight of a liquid, water immiscible oil
comprising at least one polyunsaturated fatty acid, at least one
derivative of a polyunsaturated fatty acid or mixtures thereof,
about 48% by weight of a combination of sugar and starch and about
12% by weight other ingredients.
32. The method of claim 31 wherein the effervescent composition
comprises about 10% by weight EPA, DHA or derivatives thereof.
33. The method of claim 18 wherein the effervescent composition
further comprises a sweetening agent, flavor agent, color agent or
mixture thereof.
34. The method of claim 33 wherein the sweetening agent is stevia.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation application of U.S.
patent application Ser. No. 12/392,833, filed Feb. 25, 2009, which
is incorporated herein by reference in its entirety for all
purposes.
BACKGROUND OF THE INVENTION
[0002] It has become increasingly important for the prevention and
treatment of disease as well as the maintenance of good health for
people to supplement the normal intake of food with nutritional
and/or dietary supplements. Typically, these substances are
required to be taken several times a day in order to fulfill the
daily dosage requirements. Many nutritional and/or dietary
substances are not well stored by the body requiring frequent
dosing. However, the more doses required, the less compliance there
is by the patient. People simply will not take the number of pills
required to complete the daily dosage requirements. The reasons for
failing to take proper dosages include inconvenience, difficulty in
swallowing pills, forgetfulness and the like. In addition, the
generally poor taste of many nutritional and/or dietary substances
adds to the difficulty in completing dosage regimens.
[0003] There have been efforts to develop dosage systems which seek
to make active ingredients more pleasant and effective for the
consumer. In order to provide a pleasant tasting composition and
one which provides the desired benefits, it is necessary for the
nutritional and/or dietary dosage system meet the following
requirements.
[0004] The system can provide for both nutritional and/or dietary
active ingredients. The formulation must be readily dissolvable in
a liquid, particularly water, to provide a pleasant tasting drink.
Finally, administration of the composition can be sufficient to
provide an optimum delivery of the active ingredients so that the
composition is effective until the next dosage which may be as much
as approximately 24 hours later.
[0005] Efforts have been made to meet the above-stated criteria of
a nutritional and/or dietary supplement formulation. For example,
U.S. Pat. No. 5,055,306, issued Oct. 8, 1991 to Barry et al.,
discloses a granular sustained-release formulation of a
pharmacologically active substance presented in the form of a
tablet, said tablet comprising sufficient granules to provide a
predetermined dose or number of doses of the pharmacologically
active substance and effervescent or water-dispersible ingredients,
each of said granules having a diameter of preferably between 0.5
and 2.5 mm and comprising (a) a core comprising one or more
pharmacologically active substances and preferably one or more
excipients, and (b) a coating covering substantially the whole
surface of the core and comprising 100 parts of a water insoluble
but water swellable acrylic polymer and from 20 to 70 parts of a
water soluble hydroxylated cellulose derivative, the weight of the
coating being from 2 to 25% of the weight of the core.
[0006] U.S. Pat. No. 5,178,878, issued Jan. 12, 1993 to Wehling et
al., discloses a pharmacological dosage form incorporating
microparticles which are susceptible to rupture upon chewing or
which are adapted to provide substantially immediate release of the
pharmacological ingredient contained in the microparticles. The
microparticles are provided as a tablet with an effervescent
disintegration agent. When the tablet is taken orally, the
effervescent disintegration agent aids in rapid dissolution of the
tablet and hence permits release of the microparticles, and
swallowing of the microparticles, before the pharmaceutical
ingredient is released from the microparticles. The system
therefore provides effective taste masking. The pharmaceutical
ingredient can be a dietary supplement including cod liver oil or
fish oil.
[0007] The microparticle may be provided as a microcapsule or as a
matrix-type microparticle. Microcapsules typically incorporate a
discrete mass of the pharmaceutical ingredient surrounded by a
discrete, separately observable coating of the protective material.
Conversely, in a matrix-type particle, the pharmaceutical
ingredient is dissolved, suspended or otherwise dispersed
throughout the protective material. Certain microparticles may
include attributes of both microcapsules and matrix-type particle.
For example, a microparticle may incorporate a core incorporating a
dispersion of the pharmaceutical ingredient in a first protective
material and a coating of a second protective material, which may
be the same as or different from the first protective material
surrounding the core. Alternatively, a microparticle may
incorporate a core consisting essentially of the pharmaceutical
ingredient and a coating incorporating the protective material, the
coating itself having some of the pharmaceutical ingredient
dispersed within it.
[0008] Prompt release of the microparticles is said to be
preferred. However, the protective material utilized in the
microparticle desirably should not dissolve instantaneously in
water or saliva. That is, the microparticle should resist
dissolution and release for a period of time, typically a few
seconds or so, sufficient to permit the patient to swallow the
released microparticles as the tablet disintegrates. It is said the
microparticles made using any of the polymeric protective materials
disclosed in the '878 patent will not dissolve instantaneously.
[0009] U.S. Pat. No. 5,560,928, issued Oct. 1, 1996 to DeFelice,
discloses a composition and method of using the same which provides
in as little as a single dose covering a 24 hour period a
nutritional and/or dietary supplement which provides administration
of water soluble and water insoluble active ingredients for
immediate and sustained-release delivery. The dietary supplement
can include cod liver oil or fish oil. The active ingredient can be
microencapsulated by a process in which the active ingredient is
coated with a continuous film of a natural or synthetic polymer. It
is said that microencapsulation of a water insoluble substance can
function to mask unpleasant tastes but is principally used for
slowing down the rate of release of the active ingredient to
provide a sustained-release formulation.
[0010] U.S. Pat. No. 6,071,539, issued Jun. 6, 2000 to Robinson et
al.; U.S. Pat. No. 6,488,961; issued Dec. 3, 2002 to Robinson et
al.; and U.S. Pat. No. 6,649,186, issued Nov. 18, 2003 to Robinson
et al., each disclose effervescent granules having a controllable
rate of effervescence. The granules comprise an acidic agent, an
alkaline agent, a hot-melt extrudable binder capable of forming a
eutectic mixture with the acidic agent and, optionally, a
plasticizer. The effervescent granules are made by a hot-melt
extrusion process. Examples of the hot-melt extrudable binders
include starch, sugars and invert sugars. The effervescent granules
can be formulated in a variety of forms such as a tablet, capsule,
suspension, reconstitutable powder base for a carbonated beverage
and suppository. The granules can contain a dietary supplement.
Examples of dietary supplements include cod liver oil and fish
oil.
[0011] U.S. Pat. No. 6,811,793, issued Nov. 2, 2004 to Wehling,
discloses a tablet that includes stevia, water soluble binder,
water soluble lubricant, active agent and effervescent agent. The
active agent can be a dietary supplement. Examples of dietary
supplements include cod liver oil and fish oils.
[0012] U.S. Pat. No. 7,247,324, issued Jul. 24, 2007 to Wehling et
al., discloses a method of using guava extract that includes
administering alcohol to a mammal, and administering guava extract
within no greater than 12 hours of administering the alcohol. The
guava extract can be administered as an effervescent powder,
powdered drink mix or effervescent granulation. When in the form of
a tablet, the effervescent composition preferably includes a
binder. Examples of suitable binders include starches.
SUMMARY OF THE INVENTION
[0013] The present invention provides an effervescent composition
comprising a dry, free-flowing powder comprising (a) microcapsules
comprising a hollow, solid, water soluble outer shell comprising a
starch, a sugar or mixtures thereof and an inner core comprising a
liquid, water immiscible oil comprising at least one
polyunsaturated fatty acid, at least one derivative of a
polyunsaturated fatty acid or mixtures thereof, and (b) an
effervescing agent.
[0014] The present invention further provides a method of
administering a liquid, water immiscible oil comprising at least
one polyunsaturated fatty acid, at least one derivative of a
polyunsaturated fatty acid or mixtures thereof to a subject
comprising (1) providing an effervescent composition comprising a
dry, free-flowing powder comprising (a) microcapsules comprising a
hollow, solid, water soluble outer shell comprising a starch, a
sugar or mixtures thereof and an inner core comprising a liquid,
water immiscible oil comprising at least one polyunsaturated fatty
acid, at least one derivative of a polyunsaturated fatty acid or
mixtures thereof, and (b) an effervescing agent, (2) mixing the
effervescent composition with an aqueous liquid, and (3)
administering the resulting mixture to the subject.
DETAILED DESCRIPTION OF EMBODIMENTS
Effervescent Agent
[0015] As used herein, "effervescence" means the evolution of
bubbles of gas from a liquid as the result of a bubble or gas
generating chemical reaction. The bubble or gas generating reaction
of the effervescent couple in the effervescent composition of this
invention is most often the result of the reaction of an acidic
agent and an alkaline agent. The reaction of these two general
classes of compounds produces a gas upon contact with water or an
aqueous solution.
[0016] As used herein, the term "acidic agent" refers to any
compound or material that can serve as a proton source and can
react with the alkaline agent to form a gas causing a solution
containing them to effervesce. The acidic agent can have more than
one acid dissociation constant, i.e. more than one acid functional
group. The acidic agent can be any organic or inorganic acid in the
free acid, acid anhydride and acid salt form. An acidic agent which
is in solid state at room temperature and shows pH 4.5 or lower
when saturated into water at room temperatures or its acid alkali
metal salts (e.g. sodium salt, potassium salt, etc.) can be
employed. As the acidic agent for the effervescent compositions of
this invention, a compound which is not harmful to animals
including man is desirably employed. The acidic agent can be
tartaric acid, citric acid, maleic acid, fumeric acid, malic acid,
adipic acid, succinic acid, lactic acid, glycolic acid, alpha
hydroxy acids, ascorbic acid, amino acids and their alkali metal
acid salts. Even in the case of an acid substance such as
phosphoric acid or pyrophosphoric acid or other inorganic acids
which is liquid or in liquid state at room temperature, when their
acid alkali metal salts are solid at room temperature, those acid
alkali metal salts can be employed as acidic agents. Among the
above-mentioned acidic agents, those having a relatively large acid
dissociation constant (103 or more) and a small hygroscopicity
(critical humidity at 30.degree. C. is 40% RH or more) are
preferably employed. Preferably, the acidic agents dissolves
rapidly (if not essentially instantaneously) in water or an aqueous
solution.
[0017] As used herein, the term "alkaline agent" means an alkaline
compound that releases a gas, or causes a solution to effervesce,
when exposed to a proton source such as an acidic agent or water.
The alkaline agent can be a carbon dioxide gas precursor, an oxygen
gas precursor or a chlorine dioxide gas precursor, but is
preferably a carbon dioxide gas precursor.
[0018] When the alkaline agent is a carbon dioxide precursor,
compounds such as carbonate, bicarbonate, sesquicarbonate and
hydrogencarbonate salts (in this specification, carbonate and
hydrogencarbonate, or bicarbonate, are generically referred to as
carbonate) of potassium, lithium, sodium, calcium, ammonium, or
L-lysine carbonate, arginine carbonate, sodium glycine carbonate,
sodium amino acid carbonate can be used. When the alkaline agent is
an oxygen gas precursor, compounds such as anhydrous sodium
perborate, effervescent perborate, sodium perborate monohydrate,
sodium per-carbonate and sodium dichloroisocyannurate can be used.
When the alkaline agent is a chlorine dioxide (ClO.sub.2)
precursor, compounds such as sodium hypochlorite and calcium
hypochlorite can be used.
[0019] Where the effervescent agent includes two mutually reactive
components, such as an acidic agent and an alkaline agent, it is
preferred, although not necessary, that both components react
completely. Therefore, a ratio of components which provides for
equal amounts of reaction equivalents is preferred. For example, if
the acid used is diprotic, then either twice the amount of a
mono-reactive carbonate alkaline agent, or an equal amount of a
all-reactive alkaline agent should be used for complete
neutralization to be realized. However, in other embodiments of the
present invention, the amount of either the acidic agent or the
alkaline agent can exceed the amount of the other component. This
can be useful to enhance taste and/or performance of an
effervescent composition of the present invention containing an
overage of either component. By controlling the relative ratio of
acidic agent:alkaline agent, the effervescent composition can be
used to regulate the pH of their environment.
[0020] The ratio of the above-mentioned acidic agent and alkaline
agent can also be determined according to the pH required for
dissolving an additional ingredient(s) included in an effervescent
composition of the present invention. When the solubility of the
additional ingredient(s) increases at the acid side, the pH of the
solution is lowered by adding the acidic agent in an amount more
than equivalent to the alkaline agent. When the solubility of the
additional ingredient(s) increases at the basic side, the pH of the
solution is raised by adding the alkaline agent in an amount more
than equivalent to the acidic agent. In either case, the pH near
the acidic agent immediately after the dissolution is low, while
the pH near an alkaline agent is high. In a case where the
solubility of the additional ingredient(s) does not depend on pH,
the ratio of an acidic agent and an alkaline agent can be
optionally selected.
[0021] The amount of carbon dioxide precursor, i.e. alkaline agent,
to be incorporated is proportional to the volume of carbon dioxide
gas generated. When it is desired to increase the dissolution rate
of an additional ingredient included in an effervescent composition
of this invention, it can be advantageous to increase the amount of
carbon dioxide precursor accordingly. The amount of effervescent
agent is usually selected from the range of from about 1% to about
10%, preferably from about 1.5% to 5% by weight based on the weight
of the effervescent composition.
[0022] An acidic agent and a carbon dioxide precursor are used
respectively in a powdery or granular state, usually 90% or more of
them being capable of passing through a 100 mesh (150.mu.)
screen.
Nutritional, Dietary, Medicinal and Nutraceutical Supplements
[0023] The effervescent compositions of the present invention
contain a water-immiscible, liquid (at room temperature)
nutritional, dietary, medicinal, or nutraceutical supplement (the
term "nutraceutical" is a portmanteau of nutrition and
pharmaceutical and refers to extracts of foods claimed to have a
medicinal effect on human or animal health). Examples of such
water-immiscible, liquid supplements include, but are not limited
to, marine oils, sea oils, algae based omega-3 fatty acids or
derivatives thereof, alpha linolenic acid, Vitamin A, Vitamin D,
Vitamin E, hill oil and fish oil. Fish oil is a preferred
supplement.
[0024] Fish oil is oil derived from the tissues of oily fish. Fish
oil is recommended for a healthy diet because it contains the
omega-3 polyunsaturated fatty acids, eicosapentaenoic acid (EPA),
and docosahexaenoic acid (DHA), precursors to eicosanoids that
reduce inflammation throughout the body. Fish do not actually
produce omega-3 fatty acids, but instead can accumulate them from
consuming microalgae that produce these fatty acids, as is the case
with fish like herring, sardines and cod. Cod liver oil is one
example of a fish oil.
[0025] The oil used in the effervescent compositions of this
invention can be diluted prior to microencapsulation with liquid,
essential fatty acids. These include, but are not limited to, flax
seed oil (omega-3), oleic acid (omega-9), borage oil (omega-6) and
primrose oil (omega-6)
Omega-3 Polyunsaturated Fatty Acids
[0026] As used herein, the term "omega-3 polyunsaturated fatty
acid(s)" refers to a family of unsaturated fatty carboxylic acids
that have in common a carbon-carbon bond in the n-3 position (i.e.,
the third bond from the methyl end of the molecule). Typically,
they contain from about 16 to about 24 carbon atoms and from three
to six carbon-carbon double bonds. Omega-3 polyunsaturated acids
can be found in nature, and these natural omega-3 polyunsaturated
acids frequently have all of their carbon-carbon double bonds in
the cis-configuration.
[0027] Examples of omega-3 polyunsaturated fatty acids include, but
are not limited to, 7,10,13-hexadecatrienoic acid (sometimes
abbreviated as 16:3 (n-3)); 9,12,15-octadecatetrienoic acid
(.alpha.-linolenic acid (ALA), 18:3 (n-3));
6,9,12,15-octadecatetraenoic acid (stearidonic acid (STD), 18:4
(n-3)); 11,14,17-eicosatrienoic acid (eicosatrienoic acid (ETE),
20:3 (n-3)); 8,11,14,17-eicosatetraenoic acid (eicosatetraenoic
acid (ETA), 20:4 (n-3)); 5,8,11,14,17-eicosapentaenoic acid
(eicosapentaenoic acid (EPA), (20:5 (n-3));
7,10,13,16,19-docosapentaenoic acid (docosapentaenoic acid (DPA),
22:5 (n-3)); 4,7,10,13,16,19-docosahexaenoic acid (docosahexaenoic
acid (DHA), 22:6 (n-3)); 9,12,15,18,21-tetracosapentaenoic acid
(tetracosapentaenoic acid, 24:5 (n-3)); and
6,9,12,15,18,21-tetracosahexaenoic acid (tetracosahexaenoic acid,
24:6 (n-3)).
[0028] Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
are found in nature in fish oils, and have been used in a variety
of dietary/therapeutic compositions. EPA and DHA are preferred
omega-3 polyunsaturated fatty acids in the present invention.
Omega-3 Polyunsaturated Fatty Acid Derivatives
[0029] As used herein, the teem "omega-3 polyunsaturated fatty acid
derivative(s)" refers to omega-3 polyunsaturated fatty acids that
have been reacted with another compound or otherwise modified so
that the omega-3 polyunsaturated fatty acid no longer contains a
free carboxylic acid. Examples of omega-3 polyunsaturated fatty
acid derivatives include salts, esters (such as ethyl esters) and
glycerides of omega-3 polyunsaturated fatty acids.
[0030] As used herein, the teen "glyceride" means a glycerol
molecule (i.e., OHCH.sub.2CHOHCH.sub.2OH) in which one, two or all
three of the hydroxyls have been esterified with a carboxylic acid,
e.g., an omega-3 polyunsaturated acid. Thus, "triglyceride" refers
to glycerides in which all three hydroxyls on the glycerol have
been esterified with (the same or different) carboxylic acids.
"Diglyceride" refers to glycerides in which only two of the
hydroxyls on the glycerol have been esterified with (the same or
different) carboxylic acids. "Monoglyceride" refers to glycerides
in which only one hydroxyl on the glycerol has been esterified with
a carboxylic acid.
Making Microcapsules
[0031] The microcapsules' hollow, solid, water soluble shell is
comprised of sugar and starch. One example of a useful sugar is a
glucose sugar such as a glucose syrup. The starch may be sodium
octenyl succinate. It is important to note that the shell material
is not gelatin. The starch and sugar materials are used in amounts
effective to produce a solid, water soluble outer shell and
free-flowing microcapsules. The amount of starch and sugar can vary
depending upon the particular starch and sugar used, as well as the
particular processing conditions employed. Typically, though, the
starch and sugar are used in approximately equal amounts. Thus, in
one embodiment, the weight ratio of sugar (e.g., glucose syrup) to
starch (e.g., sodium octenyl succinate) is about 1.2:1. However,
this weight ratio could vary by 15% or more in either
direction.
[0032] The microcapsules can be made by known microencapsulation
techniques. Basically, the sugar/starch material for the outer
shell (plus other ingredients if desired) can be dissolved in a
suitable solvent such as food grade alcohol (the solvent evaporates
from the shell material during the process). The material for the
outer shell and the oil (e.g., marine oil diluted with essential
fatty acids if desired) are each fed to separate fine spray nozzles
which are facing each other inside a suitable vessel. As the two
materials contact each other, the shell material surrounds the oil
droplets and hardens to form the outer shell. The process is
typically conducted at an elevated temperature (but not at a
temperature that will damage the oil or shell material), and in an
inert atmosphere. The microcapsules can be dried at elevated
temperature, sorted by size and collected.
[0033] The composition may include about 7.5% to about 50%, for
example about 35%, by weight based on the total weight of the
composition of oil, e.g., marine oil such as fish oil, within the
microcapsules. The composition may also include about 45% to about
90% packaging. Packaging may include, but is not limited to, sugar
or gelatin.
[0034] Typically, the microcapsules will be about 0.01 to about 0.1
mm in diameter. When added to an aqueous liquid (e.g., water), the
outer shell dissolves (preferably essentially instantaneously),
thereby releasing the oil.
[0035] The composition can also include other ingredients
including, e.g., flavor agents, fillers, surfactants (e.g.,
polysorbate 80 and sodium lauryl sulfate), color agents including,
e.g., dyes and pigments, sweeteners, antioxidants and additional
ingredients. These other ingredients can be included in the
material that forms the hollow, solid, water soluble shell, or may
be used separately.
Flavor Agents
[0036] Useful flavor agents include natural and synthetic flavoring
sources including, but not limited to, volatile oils, synthetic
flavor oils, flavoring aromatics, oils, liquids, oleoresins and
extracts derived from plants, leaves, flowers, fruits, stems and
combinations thereof. Useful flavor agents include, e.g., citric
oils, e.g., lemon, orange, lime and grapefruit, fruit essences
including, e.g., apple, pear, peach, banana, grape, berry,
strawberry, raspberry, blueberry, blackberry, cherry, plum,
pineapple, apricot, and other fruit flavors. Other useful flavor
agents include, e.g., aldehydes and esters (e.g., benzaldehyde
(cherry, almond)), citral, i.e., alpha-citral (lemon, lime), neral,
i.e., beta-citral (lemon, lime), decanal (orange, lemon), aldehyde
C-8 (citrus fruits), aldehyde C-9 (citrus fruits), aldehyde C-12
(citrus fruits), tolyl aldehyde (cherry, almond),
2,6-dimethyloctanal (green fruit), 2-dodedenal (citrus, mandarin)
and mixtures thereof, chocolate, cocoa, almond, cashew, macadamia
nut, coconut, mint, chili pepper, pepper, cinnamon, vanilla, tooty
fruity, mango and green tea. Mixtures of two or more flavor agents
may also be employed. When a flavor agent is used, the amount
employed will depend upon the particular flavor agent used.
However, in general, the flavor agent can constitute from about 5%
to about 50% by weight of the effervescent composition.
Color Agents
[0037] Useful color agents include, e.g., food, drug and cosmetic
(FD&C) colors including, e.g., dyes, lakes, and certain natural
and derived colorants. Useful lakes include dyes absorbed on
aluminum hydroxide and other suitable carriers. Mixtures of color
agents may also be employed. When a color agent is employed, the
amount used will depend upon the particular color agent used.
However, in general, the color agent can constitute from about 0.5%
to about 5% by weight of the effervescent composition.
Sweetening Agent
[0038] Natural and/or artificial sweetening agents can also be
added to the effervescent composition. Examples of sweeteners
include sugars such as sucrose, glucose, invert sugar, fructose,
and mixtures thereof, saccharin and its various salts (e.g., sodium
and calcium salt of saccharin), cyclamic acid and its various
salts, dipeptide sweeteners (e.g., aspartame), dihydrochalcone, and
sugar alcohols including, e.g., sorbitol, sorbitol syrup, mannitol
and xylitol, and combinations thereof. Natural sweeteners that can
be employed include, but are not limited to, luo han, stevia or
mixtures thereof. Luo han sweetener is derived from luo han guo
fruit (siraitia grosvenorii) that is mainly found in China. It is
about 300 times sweeter by weight than sucrose. Luo han is
commercially available from, e.g., Barrington Nutritionals
(Harrison, N.Y.). Stevia is derived from a South American herb,
Stevia rebaudiana. It can be up to about 300 times sweeter than
sucrose. Because luo han and stevia have such a sweet taste, only a
small amount need be used in the effervescent composition. When a
sweetening agent is employed the amount used will depend upon the
particular sweetening agent used. However, in general, the
sweetening agent can constitute from about 0.0005% to about 30% by
weight of the effervescent composition. When an agent as sweet as
stevia or luo han is used, very small amounts of the sweetener
(such as about 0.0005% to about 0.1%, about 0.005% to about 0.015%,
or about 0.002% to about 0.003% by weight) can be used.
Additional Ingredients
[0039] The effervescent compositions of the present invention can
contain additional ingredients. Examples of such additional
ingredients include, but are not limited to, vitamins, minerals
and/or herbs.
[0040] As used herein, the term "vitamin" refers to trace organic
substances that are required in the diet. For the purposes of the
present invention, the term vitamin(s) include, without limitation,
thiamin, riboflavin, nicotinic acid, pantothenic acid, pyridoxine,
biotin, folic acid, vitamin B 12, lipoic acid, ascorbic acid,
vitamin A, vitamin D, vitamin E and vitamin K. Also included within
the term vitamin are the coenzymes thereof. Coenzymes are specific
chemical forms of vitamins. Coenzymes include thiamine
pyrophosphates (TPP), flavin mononucleotide (FMM), flavin adenine
dinucleotive (FAD), Nicotinamide adenine dinucleotide (AND),
Nicotinamide adenine dinucleotide phosphate (NADP), Coenzyme A
(CoA), Coenzyme Q10 (CoQ10), pyridoxal phosphate, biocytin,
tetrahydrofolic acid, coenzyme B12, lipoyllysine, 11-cis-retinal,
and 1,25-dihydroxycholecalciferol. The term vitamin(s) also
includes choline, camitine, and alpha, beta, and gamma
carotenes.
[0041] As used herein, the term "mineral" refers to inorganic
substances, metals, and the like required in the human diet. Thus,
the term "mineral" as used herein includes, without limitation,
calcium, iron, zinc, selenium, copper, iodine, magnesium,
phosphorus, chromium and the like, and mixtures thereof. Compounds
containing these elements are also included in the term
"mineral."
[0042] As used herein, the term "herb" refers to organic substances
defined as any of various often aromatic plants used especially in
medicine or as seasoning. Thus, the term "herb" as used herein
includes, but is not limited to, black currant, ginsing, ginko
bilboa, cinnamon and the like, as well as mixtures thereof.
Compounds containing these elements are also included in the term
"herb."
[0043] Other ingredients that can be used include antioxidants,
glucosamine and mixtures thereof.
[0044] These other ingredients should be used in effective amounts.
Depending upon the particular ingredient used, and its desired
effect, the effective of these other ingredients can vary
considerably.
[0045] The effervescent composition can be made by simply mixing
the (preferably dry, free-flowing) components. This is preferably
done in a very dry, non-oxygen (e.g., nitrogen) environment. Once
mixed, the effervescent composition should be packaged quickly.
[0046] A typical effervescent composition of the present invention
is comprised of about 40% by weight omega-3 polyunsaturated fatty
acids or derivatives thereof (such as glycerides, e/g/,
triglycerides), about 48% by weight of the sugar/starch shell
composition, and about 12% by weight other ingredients. Typically,
at least about 10% by weight of the effervescent composition is a
mixture of EPA and DHA (or derivatives thereof).
[0047] The amount of the effervescent composition of the invention
that is effective will vary depending upon the condition being
treated, and can be determined by standard clinical techniques. In
addition, in vitro or in vivo assays can optionally be employed to
help identify optimal dosage ranges. The precise dose to be
employed will also depend on the relative amounts of the components
of the effervescent compositions of the invention and the
seriousness of the condition being treated and should be decided
according to the judgment of the practitioner and each subject's
circumstances. However, suitable effective dosage amounts for the
compositions of the invention typically provide at least about 500
mg of the oil, e.g., marine oil. In one embodiment, the dose
provides at least 500 mg of a combination of EPA and DHA or
derivatives thereof. Preferably, the combination contains no less
than 200 mg each of EPA and DHA or derivatives thereof.
[0048] The following examples demonstrate, but do not limit, the
present invention.
EXAMPLES
[0049] There are numerous variations on the embodiments of the
present invention illustrated in the Examples which are possible in
light of the teachings supporting the present invention. It is
therefore understood that within the scope of the following claims,
the invention may be practiced otherwise than as specifically
described or exemplified.
Example 1
[0050] The following table illustrates a composition used to make
the microcapsules of the present invention.
TABLE-US-00001 Ingredient Weight Percent Microcapsule shell
material Glucose syrup <26% Starch (sodium octenyl succinate)
<22% Mannitol (optional) <6.5% Sodium ascorbate <3% Sodium
polyphosphate <1% Mono- and diglyceride of fatty acids <1%
Tricalcium phosphate <0.3% Lecithin <0.2% Mixed tocopherol
<0.2% Ascorbyl palmitate <0.2% Natural flavor <0.2% Marine
oil Cod liver oil <40%
[0051] The cod liver oil is microencapsulated in the shell
composition using techniques described above. The resulting
free-flowing powder is blended with a powdered effervescing agent
to produce the effervescent composition of the present
invention.
[0052] Although specific embodiments of the present invention have
been described, it will be understood by those of skill in the art
that there are other embodiments that are equivalent to the
described embodiments. Accordingly it is to be understood that the
invention is not to be limited by the specific illustrated
embodiments.
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